Synlogic Announces International Nonproprietary Name Selection for SYNB1934
Labafenogene marselecobac is currently being evaluated in Synpheny-3, a global pivotal clinical trial designed to evaluate the efficacy and safety of the investigational drug as a treatment for PKU. For more information about the Synpheny-3 clinical trial, visit www.pkuresearchstudy.com.
“On the heels of initiating Synpheny-3, our pivotal study for people living with PKU, receiving this INN marks another milestone as we advance this potentially transformational therapeutic to the many patients living with PKU
About labafenogene marselecobac (SYNB1934)
Labafenogene marselecobac (SYNB1934) is an orally administered, non-systemically absorbed, potential treatment for phenylketonuria (PKU), a rare metabolic disease caused by inherited mutations that impair the breakdown of phenylalanine (Phe), an amino acid found in all protein-containing foods. The goal of PKU management is to reduce plasma Phe below neurotoxic levels, reducing risk of neurocognitive complications. Current treatment options for PKU are limited due to safety and efficacy, leaving the majority of people living with PKU without medical management and with uncontrolled Phe. Synlogic designed labafenogene marselecobac to target and consume Phe in the GI tract, by applying precision genetic engineering to a well-characterized probiotic. Results to date indicate the potential for labafenogene marselecobac as the first therapeutic for PKU approved as both a monotherapy and adjunctive medical treatment, and following successful Phase 2 results, it has advanced to Synpheny-3, a global, pivotal Phase 3 study. Labafenogene marselecobac has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the FDA in addition to orphan designation from the European Medicines Agency (EMA).
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Source: Synlogic, Inc.